OTC Medication Information: S.O.S. INSTANT RESCUE

S.O.S. INSTANT RESCUE- dimethicone gel
NATURA BISSÉ INTERNATIONAL, S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Skin Protectant

INDICATIONS AND USAGE


Helps prevent, temporarily protects and helps relieve chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather

ACTIVE INGREDIENT

Dimethicone ……..1%

DOSAGE AND ADMINISTRATION

Apply as needed

INACTIVE INGREDIENTS

Water, Pentylene Glycol, Calendula Officinalis Flower Extract, Methyl Gluceth-10,
Propylene Glycol, Butylene Glycol, Aloe Barbadensis Leaf Extract, Sodium Acrylates
Copolymer, Panthenol, Allantoin, Lecithin, Glycerin, Arginine, Laureth-3, Arnica
Montana Flower Extract, Hydroxyethylcellulose, Propolis Extract, Disodium EDTA,
Potassium Sorbate, Acetyl Dipeptide-1 Cetyl Ester, Urea, Lactic Acid, Sodium Lactate,
Serine, Sorbitol, Pseudoalteromonas Ferment Extract, Sodium Benzoate, Hydrolyzed
Wheat Protein, Sodium Chloride, Hydrolyzed Soy Protein, Ascorbic Acid, Phenoxyethanol,
Caprylyl Glycol, Xanthan Gum, Citric Acid, Tripeptide-10 Citrulline, Carbomer,
Tripeptide-1, Triethanolamine.

WARNINGS

For external use only
When using this product — do not get into eyes.
Do not use on deep or puncture wounds — animal bites — serious burns.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison
Control Center right away

STOP USE

Stop Use and Ask Doctor if conditions worsens — symptoms last more than 7 days or clear up and occur again
within a few days.

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL

LABEL 4
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LABEL 3
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LABEL 2
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LABEL 1
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S.O.S. INSTANT RESCUE
dimethicone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63730-394
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 1 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
BIOTINOYL TRIPEPTIDE-1
PROPOLIS WAX
1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA
LACTIC ACID, D-
SODIUM LACTATE
ALTEROMONAS MACLEODII
BUTYLENE GLYCOL
SODIUM BENZOATE
TRIPEPTIDE-10 CITRULLINE
PROPYLENE GLYCOL, (R)-
ALLANTOIN, (+)-
ALOE VERA LEAF
ARGININE, D-
LAURETH-3
ARNICA MONTANA FLOWER
CETYL HYDROXYETHYLCELLULOSE (550000 MW)
POTASSIUM SORBATE
N-ACETYL DIPEPTIDE-1
ASCORBIC ACID
CITRIC ACID ACETATE
LECITHIN, SUNFLOWER
GLYCERIN
SORBITOL, L-
TROLAMINE
SODIUM ACRYLATE
PANTHENOL
PENTYLENE GLYCOL
CALENDULA OFFICINALIS FLOWER
CAPRYLYL GLYCOL
CARBOMER 940
WATER
SERINE, D-
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)
PHENOXYETHANOL
XANTHAN GUM
EGTA DISODIUM
METHYL GLUCETH-10
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63730-394-01 30 mg in 1 JAR None
2 NDC:63730-394-02 2 mg in 1 JAR None
3 NDC:63730-394-03 7 mg in 1 JAR None
4 NDC:63730-394-04 30 mg in 1 TUBE None
5 NDC:63730-394-05 2 mg in 1 TUBE None
6 NDC:63730-394-06 7 mg in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/08/2017
Labeler — NATURA BISSÉ INTERNATIONAL, S.A. (464431576)
Establishment
Name Address ID/FEI Operations
NATURA BISSÉ INTERNATIONAL, S.A. 464431576 manufacture (63730-394)

Revised: 03/2017 NATURA BISSÉ INTERNATIONAL, S.A.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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